Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Eligible subjects were randomised in a 2:1 ratio to receive either liraglutide 3.0 mg or liraglutide placebo. Subjects were stratified based on pre-diabetes status at screening and further on baseline body mass index.

Reporting Groups

Description

Liraglutide 3.0 mg, no Pre-diabetes

Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.

Liraglutide Placebo, no Pre-diabetes

Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.

Liraglutide 3.0 mg, Pre-diabetes

Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.

Liraglutide Placebo, Pre-diabetes

Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.

Participant Flow for 2 periods

Period 1: Main Period: Week 0 to Week 56

Liraglutide 3.0 mg, no Pre-diabetes

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Liraglutide Placebo, no Pre-diabetes

Liraglutide 3.0 mg, Pre-diabetes

Liraglutide Placebo, Pre-diabetes

STARTED

959

0
[1]

0
[1]

487

1528

757

Exposed

957

0

0

487

1524

755

COMPLETED

679

0

0

296

1110

505

NOT COMPLETED

280

0

0

191

418

252

Adverse Event

86

0

0

16

152

29

Lack of Efficacy

11

0

0

14

12

22

Protocol Violation

25

0

0

18

40

20

Withdrawal by Subject

122

0

0

114

172

147

Unclassified

36

0

0

29

42

34

[1]

This arm is not considered for main period as these subjects belong to re-randomised period

Period 2: Re-randomised Period: Week 56 to Week 68

Liraglutide 3.0 mg, no Pre-diabetes

Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)

Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)

Liraglutide Placebo, no Pre-diabetes

Liraglutide 3.0 mg, Pre-diabetes

Liraglutide Placebo, Pre-diabetes

STARTED

0
[1]

351

350

304

0
[1]

0
[1]

COMPLETED

0

342

343

289

0

0

NOT COMPLETED

0

9

7

15

0

0

Adverse Event

0

1

1

2

0

0

Lack of Efficacy

0

0

0

1

0

0

Protocol Violation

0

1

0

3

0

0

Withdrawal by Subject

0

6

4

7

0

0

Unclassified

0

1

2

2

0

0

[1]

This arm is not considered for re-randomised period as these subjects belong to main period.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Liraglutide 3.0 mg, no Pre-diabetes

Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.

Liraglutide Placebo, no Pre-diabetes

Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.

Liraglutide 3.0 mg, Pre-diabetes

Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.

Liraglutide Placebo, Pre-diabetes

Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
When the primary results are available, Novo Nordisk plans to discuss the interpretation of these with the principal Investigator, but reserves the right to release results that may impact Novo Nordisk financial expectations (e.g. a press release directly to the public or similar) without prior consultation with the remaining participating Investigators. Novo Nordisk reserves the right not to release data until specified milestones, e.g. a clinical trial report is available.